Roche Recalls ACCU-CHEK Compact Plus Test Strips Due to Ceftriaxone Interference
Roche is recalling ACCU-CHEK Compact Plus test strips because they may produce erroneously low blood glucose readings in patients taking Ceftriaxone.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may produce inaccurate readings, posing a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Roche Diabetes Care is recalling ACCU-CHEK Compact Plus test strips. The recall is due to the potential for the test strips to produce erroneously low blood glucose readings in patients who are undergoing Ceftriaxone therapy. This specific interference is not described in the product labeling.
The affected product is the ACCU-CHEK Compact Plus Test Strips, manufactured by Roche Diagnostics Operations, Inc. These strips are used with the ACCU-CHEK Compact Plus Blood Glucose Meter to measure glucose in fresh capillary whole blood samples. The recall covers 590,136 boxes of the product, which were distributed nationwide.
Patients using these test strips who are currently taking Ceftriaxone should be aware that their blood glucose readings may be inaccurate. The source text does not specify additional consumer actions beyond the recall notice.
The recalled product
- Product
- ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count retail strip; 51 count MedBen strip 51 count Mail Order strip; Sample Kit 16 per case. The ACCU-CHEK Compact Plus Test Strips are for use…
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Hazard
- Affected units
- 590,136
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 5599423160
- 5599415160
- 5919967160
- 5919959160
- 5919983160
- 5907675001
Distribution
Distributed nationwide across the United States.
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