Recall Z-1881-2013
Siemens Healthcare Diagnostics, Inc · initiated May 10, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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).
Codes / lots: Per recall strategy.
Reason for recall
A rare variant of TSH, identified in a small cluster of patients, is not detected.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1881-2013
- Initiated
- May 10, 2013
- Posted by FDA
- August 6, 2013
- Terminated
- May 10, 2016
- Product code
- JLW – Radioimmunoassay, Thyroid-Stimulating Hormone
- Quantity
- 172913
- 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…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc, East Walpole, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1882-2013 Class II | Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure…A rare variant of TSH, identified in a small cluster of patients, is not detected. | 05/10/2013Terminated |
| Z-1883-2013 Class II | Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to…A rare variant of TSH, identified in a small cluster of patients, is not detected. | 05/10/2013Terminated |
| Z-1884-2013 Class II | Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to…A rare variant of TSH, identified in a small cluster of patients, is not detected. | 05/10/2013Terminated |
| Z-1885-2013 Class II | IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T…A rare variant of TSH, identified in a small cluster of patients, is not detected. | 05/10/2013Terminated |
| Z-1886-2013 Class II | IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 -…A rare variant of TSH, identified in a small cluster of patients, is not detected. | 05/10/2013Terminated |