Z-0835-06

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

Name: Z-0835-06 EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin immunological test system; 192...
Creator: Thera Test Laboratories, Inc.
Published: 2006-01-11
License: https://open.fda.gov/license/

Theratest Laboratories, Inc. / initiated 2006-01-11 / Terminated

FDA source

Thera Test Laboratories, Inc. began a recall of EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin immunological test system; 192 tests per kit; catalog #201-204; Thera Test... on 2006-01-11. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0835-06
Status: Terminated
Initiated: 2006-01-11
Posted: 2006-05-04
Terminated: 2006-05-03
Recalling firm: Theratest Laboratories, Inc.
Product: EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin immunological test system; 192 tests per kit; catalog #201-204; Thera Test Laboratories Inc., 1111 North Main Street, Lombard, IL 60148
Product code: MID System, Test, Anticardiolipin Immunological
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.
FDA root cause: Other
Action: 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.
Quantity in commerce: 53 kits
Distribution: California, Connecticut, Maryland, Pennsylvania, Ohio, New Jersey and Florida.
Product codes and lots: catalog #201-204: kit lot 09055514, exp. 14-JUL-2006, serum diluent lot 09055546, exp 04-OCT-2006; and kit lot 12055603, exp. 09-NOV-2006, serum diluent lot 11055595, exp. 18-NOV-2007

Product code MID

K060176Class IIEl-Acl Screen; El-Acl Igm, Igg, IgaTheratest Laboratories, Inc. / cleared 2006-02-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)