Device recall: ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 -…
Class II FDA enforcement event 65162. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
A rare variant of TSH, identified in a small cluster of patients, is not detected.
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
Siemens Healthcare Diagnostics, Inc started this device recall on 10 May 2013. The firm address in the FDA record is in East Walpole, MA. FDA put the recall in Class II. FDA event 65162 has 6 product records. The first FDA enforcement report date is 14 Aug 2013. The record gives the status Terminated, with the termination date 10 May 2016.
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 . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT,…
Recalling firm
Siemens Healthcare Diagnostics, Inc, East Walpole, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
6 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1881-2013 | ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). | 172913 | Class II | Terminated | 14 Aug 2013 |
| Z-1882-2013 | Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). | 39763 | Class II | Terminated | 14 Aug 2013 |
| Z-1883-2013 | Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). | 33506 | Class II | Terminated | 14 Aug 2013 |
| Z-1884-2013 | Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). | 18584 | Class II | Terminated | 14 Aug 2013 |
| Z-1885-2013 | IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). | 51792 | Class II | Terminated | 14 Aug 2013 |
| Z-1886-2013 | IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). | 13462 | Class II | Terminated | 14 Aug 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 II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2013
- 1,236
- Share of these events in Class II
- 90%
- Product records in this event
- 6Median of the firm: 1
- Events of the firm on the register
- 333
Other events of the firm
Official channels
- FDA enforcement report Z-1881-2013The 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 65162. https://recallregister.com/fda/ii/65162/. Source: openFDA enforcement reports. Data through .
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) and the countries of Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT,…
- What quantity of product is in FDA event 65162?
- The event has 6 product records. The first record gives this quantity:
172913
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2013 have the same class?
- 90% of the 1,236 device events that started in 2013 are in Class II.