EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin immunological test system; 192 tests per kit;

FDA device recall Z-0835-06 · posted 2006-05-04 · Terminated

Recall details

Recalling firm

Thera Test Laboratories, Inc.

Reason for recall

The specimen diluent contained in the kits was contaminated with a fungal growth. Also, a portion of kit lot 09055514 was shipped without the Data Sheet, part #201-204.

Action taken

On 10/26/05, Thera Test telephoned the 3 accounts who received lot 09055514 without the Data Sheet in the kits, and sent them copies of the Data Sheet for insertion into the 6 kits on hand at the consignees. Between 1/4-9/06, Thera Test telephoned the 17 accounts receiving kit lots 09055514 and 12055603, and sent them follow-up letters dated 1/9/06 with replacement bottles of Specimen Diluent. The accounts were advised of the fungal contamination found in some bottles of the diluent shipped with the kit lots, and were requested to destroy any remaining bottles of the Specimen Diluent in their kits and replace them with the bottles of diluent sent with the letter.

Root cause

Other

Status

Terminated

Product code

MID

Quantity affected

53 kits

Distribution

California, Connecticut, Maryland, Pennsylvania, Ohio, New Jersey and Florida.

Date initiated

2006-01-11

Date posted

2006-05-04

Date terminated

2006-05-03

Location

Lombard, IL

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