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Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190… recallZ-1145-2019 · Roche Diagnostics Corporation · initiated Dec 17, 2018

Class II Terminated All recalls posted in April 2019

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Roche Diagnostics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update: Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays***

FDA root cause category: Device Design

What the company is doing

On 12/17/18, the firm distributed an Urgent Medical Device Correction letter to affected consignees. Customers were notified of the interference issues. The Limitations-interference section of the method sheets for the cobas c 311 analyzer and the cobas c 501, 502, 701, and 702 modules are being updated with the following claims: Bilirubin Total Gen.3 assay: Immunoglobulins: No significant interference from immunoglobulins up to a concentration of 28 g/L (187 mol/L) (simulated by human immunogloblulin G). Lactate Gen.2 assay (CSF samples): Ditaurobilirubin: No significant interference from ditaurobilirubin up to an approximate concentration of 102 mol/L (6 mg/dL). Tina-quant IGM-2 (Sensitive application): Hemolysis: No significant interference up to an H index of 600 (approximate hemoglobin concentration of 373 mol/L or 600 mg/dL). Lipemia (Intralipid): No significant interference up to an L index of 600 Customers were asked to do the following: " Be aware of the new interference claims listed in this Urgent Medical Device Correction (UMDC). This UMDC serves as labeling until the updated method sheets are available. The method sheets for the MODULAR ANALYTICS P/D modules will not be updated. " Manually update the H and L indexes for the IGMP2 sensitive application on your cobas c 311 analyzer or cobas c 501, 502, 701, and 702 modules following the instructions provided in this UMDC. " Complete all sections of the enclosed fax form (TP-00507) and fax it to 1-xxx-xxx-xxx or email it to [email protected]. " File this UMDC for future reference. When the method sheets are updated, they will be available on the diagnostics.roche.com Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions. website and on the cobas e-library. ***UPDATE: Firm sent updated communication to customers dated 5/9/2019 informing them that L and H index values

Recall details

Recall number
Z-1145-2019
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 17, 2018
Posted by the FDA
Apr 13, 2019
Recalling firm
Roche Diagnostics Corporation
Quantity
5292 analytical units
Product code
CIG
FDA submissions
K131544
Distribution
US Nationwide distribution.

Product description

Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19***05795397190, 05795648190 Product Usage: In vitro test for the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.

Code information (models, lots, serial numbers)

n/a

Other devices under the same FDA submission

7 devices cleared under K131544 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 81859).

Sources and updates

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