Z-1303-04

Roche brand Reflotron GPT (ALT) 30 test strips; catalog # 745138

Name: Z-1303-04 Roche brand Reflotron GPT (ALT) 30 test strips; catalog # 745138
Creator: Roche Diagnostics Corp.
Published: 2004-07-14
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2004-07-14 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche brand Reflotron GPT (ALT) 30 test strips; catalog # 745138 on 2004-07-14. The reason FDA records is "Coating defect may result is falsely decreased patient and/or control results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1303-04
Status: Terminated
Initiated: 2004-07-14
Posted: 2004-07-31
Terminated: 2004-10-14
Recalling firm: Roche Diagnostics GmbH
Product: Roche brand Reflotron GPT (ALT) 30 test strips; catalog # 745138.
Product code: CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
Reason for recall: Coating defect may result is falsely decreased patient and/or control results.
FDA root cause: Other
Action: Recall letters dated 7/14/04 were sent to each customer asking that use of these lots be stopped immediately. Testing labs were asked to notify the attending physician for any patients tested with these test strips.
Quantity in commerce: 197 boxes
Distribution: United States.
Product codes and lots: Lot 23717132; exp 5/31/2005.

Product code CIT

K864082Class IReflotron(r) Alt (Gpt)Boehringer Mannheim Corp. / cleared 1986-12-04

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)