Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents
FDA device recall Z-0214-05 · posted 2004-11-20 · Terminated
Recall details
- Recalling firm
- Zeus Scientific Inc
- Reason for recall
- During packaging, Lyme plates were packaged in this kit in error.
- Action taken
- Wampole Laboratories was contacted by Zeus on 8/30/3004. Wampole customers were then contacted by phone and letter to destroy all products on hand.
- Root cause
- Other
- Status
- Terminated
- Product code
- MID
- Quantity affected
- 25 kits
- Distribution
- 25 units were sent directly from Zeus to their direct account Wampole Laboratories. The distributor contacted their customers to discard all affected kits. 8 units were shipped overseas to Israel. The
- Date initiated
- 2004-08-30
- Date posted
- 2004-11-20
- Date terminated
- 2006-10-03
- Location
- Somerville, NJ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM (K981021) | Zeus Scientific, Inc. | 1998-06-02 |