Device recall: ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker

Class II FDA enforcement event 79813. Recall start date: 5 Mar 2018. Status in the FDA record: Terminated. Termination date: 31 Aug 2020.

Reason for recall, in the words of FDA

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Tosoh Bioscience Inc started this device recall on 5 Mar 2018. The firm address in the FDA record is in Grove City, OH. FDA put the recall in Class II. FDA event 79813 has 35 product records. The first FDA enforcement report date is 13 Jun 2018. The record gives the status Terminated, with the termination date 31 Aug 2020.

FDA enforcement report The 35 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.

Recalling firm

Tosoh Bioscience Inc, Grove City, OH.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

35 product records in the event.

FDA event 79813: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2065-2018	ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker	3254	Class II	Terminated	13 Jun 2018
Z-2066-2018	ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker	15942	Class II	Terminated	13 Jun 2018
Z-2067-2018	ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker	41105	Class II	Terminated	13 Jun 2018
Z-2068-2018	ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate	1083	Class II	Terminated	13 Jun 2018
Z-2069-2018	ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker	4824	Class II	Terminated	13 Jun 2018
Z-2070-2018	ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker	12361	Class II	Terminated	13 Jun 2018
Z-2071-2018	ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker	2549	Class II	Terminated	13 Jun 2018
Z-2072-2018	ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker	733	Class II	Terminated	13 Jun 2018
Z-2073-2018	ST-AIA PACK cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac Marker	5802	Class II	Terminated	13 Jun 2018
Z-2074-2018	ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes	1358	Class II	Terminated	13 Jun 2018
Z-2075-2018	ST-AIA PACK C-Peptide II; Part Number: 025283 Assay, Diabetes	2982	Class II	Terminated	13 Jun 2018
Z-2076-2018	ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes	9625	Class II	Terminated	13 Jun 2018
Z-2077-2018	AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid	5293	Class II	Terminated	13 Jun 2018
Z-2078-2018	ST-AIA PACK TT3; Part Number: 025282 Assay, Thyroid	10424	Class II	Terminated	13 Jun 2018
Z-2079-2018	ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid	14690	Class II	Terminated	13 Jun 2018
Z-2080-2018	ST-AIA PACK FT3; Part Number: 025286 Assay, Thyroid	12055	Class II	Terminated	13 Jun 2018
Z-2081-2018	ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid	43275	Class II	Terminated	13 Jun 2018
Z-2082-2018	ST-AIA PACK TU; Part Number: 025270 Assay, Thyroid	5491	Class II	Terminated	13 Jun 2018
Z-2083-2018	ST-AIA PACK HCG; Part Number: 025261 Assay, Reproductive Hormone	12614	Class II	Terminated	13 Jun 2018
Z-2084-2018	ST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive Hormone	66	Class II	Terminated	13 Jun 2018
Z-2085-2018	ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone	1442	Class II	Terminated	13 Jun 2018
Z-2086-2018	ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone	9033	Class II	Terminated	13 Jun 2018
Z-2087-2018	ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone	4867	Class II	Terminated	13 Jun 2018
Z-2088-2018	ST-AIA PACK Estradiol; Part Number: 025274 Assay, Reproductive Hormone	16080	Class II	Terminated	13 Jun 2018
Z-2089-2018	ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone	49	Class II	Terminated	13 Jun 2018
Z-2090-2018	ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone	10023	Class II	Terminated	13 Jun 2018
Z-2091-2018	ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone	5990	Class II	Terminated	13 Jun 2018
Z-2092-2018	ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive Hormone	539	Class II	Terminated	13 Jun 2018
Z-2093-2018	ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone	10913	Class II	Terminated	13 Jun 2018
Z-2094-2018	ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic	4027	Class II	Terminated	13 Jun 2018
Z-2095-2018	ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic	752	Class II	Terminated	13 Jun 2018
Z-2096-2018	ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia	24410	Class II	Terminated	13 Jun 2018
Z-2097-2018	ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy	2867	Class II	Terminated	13 Jun 2018
Z-2098-2018	ST-AIA PACK BMG; Part Number:025259 Assay, Tumor Marker	3406	Class II	Terminated	13 Jun 2018
Z-2099-2018	ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker	1047	Class II	Terminated	13 Jun 2018

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2018: 1,074
Share of these events in Class II: 92%
Product records in this event: 35Median of the firm: 1
Events of the firm on the register: 27

Other events of the firm

Other FDA enforcement events of Tosoh Bioscience Inc
Initiated	Product (first record)	Type	Class	Records
12 Jun 2026	ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum o	Device	Class II	1
7 Aug 2020	Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrat	Device	Class II	2
22 May 2020	AIA-900 Analyzer, Part no. 022930, UDI 04560189283992	Device	Class II	1
10 Jan 2020	AIA-360 Automated Immunoassay Analyzer, Product Code 019945	Device	Class II	1
30 Nov 2018	AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12	Device	Class II	6
5 Oct 2018	Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testi	Device	Class III	1
5 Oct 2018	AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The AIA-900 is capable of performing	Device	Class II	1
5 Oct 2018	AIA-900 Analyzer, Product code 022930, 022930R	Device	Class II	1
28 Sep 2018	AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three method	Device	Class II	1
28 Sep 2018	Tosoh AIA-900 immunoassay Analyzer	Device	Class II	1

Tosoh Bioscience Inc: all 27 events

Official channels

FDA enforcement report Z-2065-2018The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 79813. https://recallregister.com/fda/ii/79813/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.
What quantity of product is in FDA event 79813?: The event has 35 product records. The first record gives this quantity: 3254
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2018 have the same class?: 92% of the 1,074 device events that started in 2018 are in Class II.