Recall Z-2967-2020 ยท JIT Calibrator, Secondary
Tosoh Bioscience Inc
Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
| Date | Sep 14, 2020 (initiated Aug 7, 2020) |
| Status | Terminated |
| Reason | Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%. |
| Root cause | Under Investigation by firm |
| Action | The firm, Tosoh Bioscience, issued an "URGENT: MEDICAL DEVICE RECALL" Letter dated August 7, 2020 via Fedex to its customers. The letter states reason for recall, health risk and action to taken: Check the lot numbers of the AIA - PACK HCG Calibrator Set and AIA-PACK HCG Calibration Verification Test Set against the lot numbers listed above. Lots not listed above are not within the scope of this recall and maybe used per AAM. Remove all affected AIA - PACK HCG Calibrator Sets and AIA - PACK HCG Calibration Verification Test Sets from your inventory. The products must be tallied including pr |
| Quantity | 289 boxes |
| Distribution | Worldwide Distribution: US (Nationwide) and countries of: Bogota, Cayman Islands, Mexico, Peru, and San Salvador. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.