Recall Z-1883-2013 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Siemens Healthcare Diagnostics, Inc
Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
| Date | Aug 6, 2013 (initiated May 10, 2013) |
| Status | Terminated |
| Reason | A rare variant of TSH, identified in a small cluster of patients, is not detected. |
| Root cause | Device Design |
| Action | 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 miti |
| Quantity | 33506 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081074 | DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691 Siemens Healthcare Diagnostics, Inc., May 23, 2008 |