—#37242

Product

Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322.

FDA product code: LCP — Assay, Glycosylated Hemoglobin
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K952337
Affected lot / code info: Lots 646340, 650984, 651640 and 653292.

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2005-02-15
Posted by FDA: 2005-03-23
Terminated: 2005-05-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #37242. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.