Device recall: Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids…

Class I FDA enforcement event 66058. Recall start date: 21 Aug 2013. Status in the FDA record: Terminated. Termination date: 15 May 2014.

Reason for recall, in the words of FDA

Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Siemens Healthcare Diagnostics, Inc. started this device recall on 21 Aug 2013. The firm address in the FDA record is in West Sacramento, CA. FDA put the recall in Class I. FDA event 66058 has 11 product records. The first FDA enforcement report date is 18 Sep 2013. The record gives the status Terminated, with the termination date 15 May 2014.

FDA enforcement report The 11 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 - USA Nationwide in the states of: AK, SC, IA, MO GA, WI, TX, KS, CA, IL, CO, AZ, SD, IN, MD, FL, MN and the countries of:Japan, France, Algeria, Germany, Austria, Romania,…

Recalling firm

Siemens Healthcare Diagnostics, Inc., West Sacramento, CA.

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

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

Products

11 product records in the event.

FDA event 66058: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2119-2013	Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.	1209 boxes, 24, 180 panels	Class I	Terminated	18 Sep 2013
Z-2120-2013	Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.	2158 boxes, 43,160 panels	Class I	Terminated	18 Sep 2013
Z-2121-2013	Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.	4319 boxes, 86, 380 panels	Class I	Terminated	18 Sep 2013
Z-2122-2013	Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.	1,324 boxes, 26,480 panels	Class I	Terminated	18 Sep 2013
Z-2123-2013	Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.	522 boxes, 10, 440 panels	Class I	Terminated	18 Sep 2013
Z-2124-2013	Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.	57,600 panels in total	Class I	Terminated	18 Sep 2013
Z-2125-2013	Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.	57,600 panels in total	Class I	Terminated	18 Sep 2013
Z-2126-2013	Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.	57,600 panels in total	Class I	Terminated	18 Sep 2013
Z-2127-2013	MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.	57,600 panels in total	Class I	Terminated	18 Sep 2013
Z-2128-2013	Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.	57,600 panels in total	Class I	Terminated	18 Sep 2013
Z-2129-2013	Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.	57,600 panels in total	Class I	Terminated	18 Sep 2013

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 I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2013: 1,236
Share of these events in Class I: 6%
Product records in this event: 11Median of the firm: 1
Events of the firm on the register: 333

Other events of the firm

Other FDA enforcement events of Siemens Healthcare Diagnostics, Inc.
Initiated	Product (first record)	Type	Class	Records
13 Jul 2026	Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL	Device	Class II	2
6 Jul 2026	Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic	Device	Class II	1
26 Jun 2026	Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL	Device	Class III	1
26 Jun 2026	Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL	Device	Class III	1
8 Jun 2026	Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.	Device	Class II	1
7 May 2026	Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay	Device	Class II	1
2 Apr 2026	epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;	Device	Class II	1
18 Mar 2026	Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.	Device	Class II	1
23 Feb 2026	Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;	Device	Class II	1
20 Jan 2026	Atellica CH Urine Albumin (UAlb). Material Number: 11537225	Device	Class II	1

Siemens Healthcare Diagnostics, Inc.: all 333 events

Official channels

FDA enforcement report Z-2119-2013The 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.

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Cite this page

Recall Register. FDA enforcement event 66058. https://recallregister.com/fda/i/66058/. 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 - USA Nationwide in the states of: AK, SC, IA, MO GA, WI, TX, KS, CA, IL, CO, AZ, SD, IN, MD, FL, MN and the countries of:Japan, France, Algeria, Germany, Austria, Romania,…
What quantity of product is in FDA event 66058?: The event has 11 product records. The first record gives this quantity: 1209 boxes, 24, 180 panels
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2013 have the same class?: 6% of the 1,236 device events that started in 2013 are in Class I.