Ortho-Clinical Diagnostics Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diagnostic use. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diagnostic use. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626.
Brand
Ortho-Clinical Diagnostics
Lot Codes / Batch Numbers
Generations 18, 19, 20, 21, and 23
Products Sold
Generations 18, 19, 20, 21, and 23
Ortho-Clinical Diagnostics is recalling Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diagnostic due to Falsely elevated Carbamazepine results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Falsely elevated Carbamazepine results.
Recommended Action
Per FDA guidance
Letters dated 5/26/05 with instructions to discontinue use and discard slides. Customers also instructed to review previous results with Laboratory Medical Director to determine need for further consultation with health care provider.
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