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Terminated

Roche ULTIMATE 5 HBA1C test kit for use with MIRA analyzers; catalog number 20755656322.

FDA Recall Z-0651-05 · Posted 2005-03-23

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeLCP
Date Initiated2005-02-15
Date Terminated2005-05-17
Product Quantity1800 kits.

Reason for Recall

The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.

Firm Action

Recall letters dated 2/15/05 were sent to each user instructing customers to run controls before the use of each cassette or kit in a lot, instead of once per lot as previously instructed, and to notify the physician at the facility.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K952337ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & PRoche Diagnostic Systems, Inc. · 1996-02-09

Official Source

View FDA Recall →

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

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