Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
- Recall Initiated
- January 12, 2020
- Posted
- March 2, 2020
- Recall Number
- Z-1421-2020
- Quantity
- 3559
- Firm Location
- Tarrytown, NY
Reason for Recall
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.
Distribution
Domestic distribution nationwide. Worldwide foreign distribution.
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
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