Recall Z-2493-2020
Radiometer Medical ApS · initiated May 26, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and ABL800Basic. The FlexQ module is optional and can be added to all models and configurations.
Codes / lots: Software versions 6.19 and below.
Reason for recall
Potential risk of patient mix-up on analyzers due to software issues.
FDA-determined cause: Software design
Action taken
On 05/26/2020, the firm sent an Urgent: Medical Device Recall letter via email to all consignees; additionally the firm will send a hard copy letter FedEx 2nd day with tracking and proof of delivery.
Details
- Recall number
- Z-2493-2020
- Initiated
- May 26, 2020
- Terminated
- February 8, 2023
- Product code
- CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Quantity
- 4,615 units
- Distribution
- US - AL, AR, AZ, BM, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY. OUS - Australia, Austria, Canada, Czech Republic, China, Croatia, Denmark, France, Finland, Germany, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Africa, South…
- Recalling firm
- Radiometer Medical ApS, Bronshoj
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2494-2020 Class II | Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI…Potential risk of patient mix-up on analyzers due to software issues. | 05/26/2020Terminated |