Device recall: Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is…

Class II FDA enforcement event 81177. Recall start date: 24 Sep 2018. Status in the FDA record: Terminated. Termination date: 9 Feb 2022.

Reason for recall, in the words of FDA

Limits of Detection (LoD) for protein, nitrite, leukocytes, and erythrocytes on the Urisys 1100 urine analyzer with Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA test strips were higher than what is listed in the test strip method sheets may lead to false negative results for the affected parameters

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

Roche Diagnostics Corporation started this device recall on 24 Sep 2018. The firm address in the FDA record is in Indianapolis, IN. FDA put the recall in Class II. FDA event 81177 has 1 product record. The first FDA enforcement report date is 7 Nov 2018. The record gives the status Terminated, with the termination date 9 Feb 2022.

FDA enforcement report The 1 product record

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.

US Nationwide Distribution

Recalling firm

Roche Diagnostics Corporation, Indianapolis, IN.

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

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

Products

1 product record in the event.

FDA event 81177: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0301-2019	Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results of Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA urine test strips for various urine analytes.:…	14,398 units	Class II	Terminated	7 Nov 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: 1Median of the firm: 1
Events of the firm on the register: 26

Other events of the firm

Other FDA enforcement events of Roche Diagnostics Corporation
Initiated	Product (first record)	Type	Class	Records
3 Jun 2019	The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form a	Device	Class II	1
4 Apr 2019	cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.	Device	Class III	2
18 Mar 2019	Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum an	Device	Class II	1
15 Mar 2019	cobas e 801 immunoassay analyzer	Device	Class II	1
4 Feb 2019	Cobas infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use	Device	Class II	1
17 Dec 2018	Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 **added as of 5/10/19	Device	Class II	3
17 Dec 2018	Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for	Device	Class II	1
14 Dec 2018	COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 0303	Device	Class II	2
13 Sep 2018	CoaguChek XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS P	Device	Class I	1
16 Jul 2018	Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer con	Device	Class II	1

Roche Diagnostics Corporation: all 26 events

Official channels

FDA enforcement report Z-0301-2019The 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 81177. https://recallregister.com/fda/ii/81177/. 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: US Nationwide Distribution
What quantity of product is in FDA event 81177?: The FDA record gives this quantity: 14,398 units
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.