Z-1927-2015Class II
LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative...
Roche Diagnostics GmbH / initiated 2015-05-07 / Terminated
Roche Diagnostics Operations, Inc. began a recall of LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein... on . FDA classified it as Class II and gives the reason as "Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid...". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-1927-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Roche Diagnostics GmbH
- Product
- LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.
- Product code
- MRR System, Test, Low Density, Lipoprotein
- Reason for recall
- Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.
- FDA root cause
- Under Investigation by firm
- Action
- Roche Diagnostics initiated a voluntary recall and the Urgent Medical Device Correction notices were sent via UPS Ground on 05/07/2015 to customers. Customers were notified of the interference and the method sheets and package inserts will be updated with the new interference claims. The firm plans to monitor any non-responding accounts and address those customers with follow-up attempts to distribute recall notices. The firm plans to conduct level B effectiveness checks via fax and phone. Until the new method sheets are available, the Urgent Medical Device Correction serves as the updated labeling. Roche is not requesting return of the affected product. Customers may contact Todd Siesky Corporate Communications Director, Phone: 317.521.3911, Fax: 317.521.4696, E-mail: [email protected]. For technical questions, contact the Customer Support Center at 1-800-428-2336
- Quantity in commerce
- 6255
- Distribution
- US (nationwide) including PR.
- Product codes and lots
- Catalog numbers 04714423190; 04711220190; 05230438190; 05230446190.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1920-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1921-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1922-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1923-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1924-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1925-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1926-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1927-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1928-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1929-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1930-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1931-2015 | Class II | Terminated | Voluntary: Firm initiated |
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