Siemens Healthcare Diagnostics, Inc.: Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143

Recall number

Z-1421-2020

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Product

Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143

Status

Open, Classified

Initiated

2020-01-12

Posted

2020-03-02

Terminated

not on file

Reason

Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate or depress sample results.

Root cause

Under Investigation by firm

Action

The firm distributed Urgent Medical Device Correction letters to all affected customers on January 17, 2020. Customers were asked to check each Atellica CH 930 Analyzer in their laboratory as well as in their inventory for impacted cuvette lot numbers ending in "17" or "18" (6th and 7th digits). These devices must be purged from the customer's inventory. If the customer does not have enough cuvette segments of the unimpacted lot in their inventory, they may contact customer service. Detailed instructions were provided in the appendices to the customer letter. ***Updated 3/2/2020*** An updated Urgent Medical Device Correction was distributed to all customers on February 26, 2020, due to the recalling firm adding cuvette segment kit lots ending in "19" to the affected products list. The follow-up communication advises customers of the potential for falsely depressed or elevated results from Atellica CH reaction cuvette segments with the kit lot ending in "19" and above, due to a cuvette defect allowing water bath to contaminate the cuvette. Customers who routinely run the CO2_c assay will be instructed to run 300 replicates of the CO2_c calibrator on their analyzer in order to cover all cuvette positions. The customers will then follow the instructions provided in the communication and will use the mean value of the 300 replicates to determine if there is cuvette impact. If all individual calibrator results are d12% of the mean calibrator value, no further action is required, and the laboratories can continue to process patient samples. If any individual calibrator result is >12% of the mean calibrator value, customers will be asked to contact Siemens Customer Care Center to determine additional action to be taken prior to processing patient samples. Customers who do not routinely run CO2_c samples in their laboratory will be instructed to run all patient samples in duplicate for every assay except Sodium, Potassium, and Chloride. Customers will be asked t

Quantity

3559

Distribution

Domestic distribution nationwide. Worldwide foreign distribution.

Lot, serial or model codes

Lots N1521417 N1522218 N1528917 N1526418 N1502518 N1527518 N1503218 N1529618 N1503918 N1530318 N1504618 N1531018 N1516318 N1531618 N1517218 N1532318 N1518318 N1535518 N1519418 N1536318 N1520118   ***new lots added 3/2/2020***  N1500119 N1520519  N1500219 N1521319  N1500620 N1522419  N1501119 N1523319  N1501520 N1526719  N1503519 N1527619  N1505619 N1528719  N1506419 N1529619  N1507919 N1533819  N1508519 N1534719  N1510619 N1535719  N1519019 N1530419  N1519719

510(k) numbers

["K161954"]

PMA numbers

not on file

Product code

JGS

Firm FEI

2432235

Firm city

Tarrytown

Firm state

NY

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

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