Roche Diagnostics Corp. Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
Lots 646340, 650984, 651640 and 653292.
Products Sold
Lots 646340, 650984, 651640 and 653292.
Roche Diagnostics Corp. is recalling Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322. due to The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026