Roche Diagnostics Corporation: Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnostic reagent system intended for use on cobas Integra for the quantitative determination of the lactate concentration in plasma and cerebrospinal fluid.

Recall number

Z-1146-2019

Recalling firm

Roche Diagnostics Corporation

Product

Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnostic reagent system intended for use on cobas Integra for the quantitative determination of the lactate concentration in plasma and cerebrospinal fluid.

Status

Terminated

Initiated

2018-12-17

Posted

2019-04-13

Terminated

2020-11-02

Reason

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***

Root cause

Device Design

Action

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 rochexxxx@stericycle.com. " 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

Quantity

5292 analytical units

Distribution

US Nationwide distribution.

Lot, serial or model codes

n/a

510(k) numbers

["K964457"]

PMA numbers

not on file

Product code

KHP

Firm FEI

1823260

Firm city

Indianapolis

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy