Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
Recall
- Recall Number
- Z-1421-2020
- Event Number
- 84788
- Firm
- Siemens Healthcare Diagnostics, Inc.
- FEI Number
- 2432235
- Product Code
- JGS
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- January 12, 2020
- Posted
- March 2, 2020
- Address
- 511 Benedict Ave, Tarrytown, NY, 10591-5005
Description
Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
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.
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
Domestic distribution nationwide. Worldwide foreign distribution.
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