Recall Z-0676-2018
Hologic, Inc. · initiated November 29, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
Codes / lots: K6030, L6010, M6007, M6032, A7024, A7056, B7017, B7042, B7057, C7053, D7008, D7043, E7058, E7082
Reason for recall
Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material from SDIX.
FDA-determined cause: Mixed-up of materials/components
Action taken
Hologic initiated the recall on Wednesday, November 29, 2017. The method of notification was via overnight FedEx.
Details
- Recall number
- Z-0676-2018
- Initiated
- November 29, 2017
- Terminated
- August 22, 2018
- Product code
- LKV – Enzyme Immunoassay, Fetal Fibronectin
- Quantity
- 165 kits
- Distribution
- United States (US), Guam (GU), Japan (JP)
- Recalling firm
- Hologic, Inc., Sunnyvale, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0677-2018 Class II | Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200QRapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products… | 11/29/2017Terminated |