ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 -… recallZ-1881-2013 · Siemens Healthcare Diagnostics, Inc · initiated May 10, 2013
Class II Terminated All recalls posted in August 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A rare variant of TSH, identified in a small cluster of patients, is not detected.
FDA root cause category: Device Design
What the company is doing
On May 10, 2013, an Important Safety Information notice was sent to all affected Siemens Healthcare Diagnostic customers in the United States. On May 10, 2013, an Urgent Field Safety Notice was sent to all customers outside of the United States. These notices inform the customer that there is a rare variant of TSH, identified in a small cluster of patients that is not detected by some Siemens assays. This notice informs customers that they should continue to use the affected TSH assays as the observed rate of occurrence during a 30-month time period was 0.6 X 10 -7 and there are strong mitigating factors. These mitigating factors include co-interpretation of TSH results in conjunction with thyroxine and TS, patient history and clinical signs and symptoms. Although Siemens believes a look back is not required as the expected frequency of the variant is extremely rare, these notices state that this decision should be made by the medical director.
Recall details
- Recall number
- Z-1881-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 10, 2013
- Posted by the FDA
- Aug 6, 2013
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Quantity
- 172913
- Product code
- JLW
- FDA submissions
- K083844
- 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, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KA, KR, KW, KZ, LB, LK, LT, LV, LY, MA, MK, MT, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, SY, TH, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XS, and ZA.
Product description
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).
Code information (models, lots, serial numbers)
Per recall strategy.
Other devices under the same FDA submission
2 devices cleared under K083844 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ADVIA Centaur® TSH3-UL 10282379Siemens Healthcare Diagnostics Inc. · RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE15 reports
- ADVIA Centaur® TSH3-UL 10282378Siemens Healthcare Diagnostics Inc. · RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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