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Terminated

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

FDA Recall Z-1303-04 · Posted 2004-07-31

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeCIT
Date Initiated2004-07-14
Date Terminated2004-10-14
Product Quantity197 boxes

Reason for Recall

Coating defect may result is falsely decreased patient and/or control results.

Firm 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.

Root Cause

Other

Distribution Pattern

United States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K864082REFLOTRON(R) ALT (GPT)Boehringer Mannheim Corp. · 1986-12-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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