Recall Z-0927-2013 ยท LSR Reagent, Borrelia Serological Reagent
Innominata Dba Genbio
ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.
| Date | Mar 8, 2013 (initiated Feb 11, 2013) |
| Status | Terminated |
| Reason | Multiple incidents of low-reacting assay plates. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Innominata dba GenBio, sent an "Urgent Product Correction" letter dated February 11, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the listed questions to determine sites risk and take the appropriate actions. For questions regarding this issue, customers may contact Bio-Rad Technical Support at : 1-800-224-6723, option #2, and then option #3 for assistance. |
| Quantity | 195 |
| Distribution | Nationwide distribution: CA, IL, MA, MD, ME, NC, ND, NJ, NY, OR, VA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911590 | IMMUNOWELL BORRELIA (LYME)TEST General Biometrics, Inc., Dec 20, 1991 |