Roche COBAS AmpliPrep Instruments Recalled Due to Disabled Clot Detection Feature
Roche is recalling 7 COBAS AmpliPrep instruments because the sample clot detection feature was disabled during quality control, potentially allowing unflagged clotted samples to be processed.
What this means for you
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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Roche Molecular Systems, Inc. is recalling 7 units of the COBAS AmpliPrep Instrument (CAP) equipped with AMPLILINK (AL) Software v.3.3.5. These automated sample processing instruments are used with CAP/CA and CAP/CTM systems. The recall affects units with serial numbers ranging from CAP 394436 to 394663.
The recall was initiated because certain instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging feature disabled during quality control release. As a result, samples that contained clots may not have been flagged, potentially compromising the integrity of the sample processing. The affected units were distributed in the states of Georgia, California, North Carolina, and Minnesota.
This recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. No specific illnesses or injuries are reported in the source text. Healthcare facilities and users of these instruments should contact Roche Molecular Systems, Inc. for instructions on how to resolve the issue.
The recalled product
- Product
- COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland
- Manufacturer
- Roche Molecular Systems, Inc.
- Affected units
- 7
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 (1)
- CAP 394436 to 394663
Distribution
Related recalls
Same manufacturer · Roche Molecular Systems, Inc.
See all →- HighRoche cobas Influenza Test Recall Due to False Negative Results
FDA (Devices) · 2023-02-15
- HighRoche Influenza A/B and RSV Test Kit Recalled for False Negative Results
FDA (Devices) · 2023-02-15
- HighRoche cobas Flu/COVID assay recalled for false negative influenza results
FDA (Devices) · 2023-02-15
- HighMedical Device Recall: Roche cobas 5800 False Results Due to Baseline Anomalies
FDA (Devices) · 2022-10-26
- ModerateCobas Liat respiratory virus analyzer units recalled for false Influenza B results
FDA (Devices) · 2022-04-06