ABL7XX Calibration 1 Solution S1720. P/N S1720, 944-024 Intended for in vitro testing of samples of whole blood for the
FDA device recall Z-0457-2009 · posted 2008-12-03 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- Reason for recall
- The firm found that for this particular lot that the barcode, used for entering the characteristics of CAL1 Solution into the analyzer, does not reflect the actual values of the solution. As a consequence, the calibration curves for these parameters and thereby the measured results for patient samples and quality controls will be biased.
- Action taken
- On, 9/2/2008 the firm sent out recall notification letters requesting their customers discard any Calibration 1 Solution (CAL1) S1720 (part number 944-024), lot WA-04, complete the attached return form and fax it to 800-736-0601. The firm will send out replacements for all affected product that the firm shows was shipped to their location. Further questions could be directed to Technical Support at 800-736-0600, option 2.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JFP
- Quantity affected
- 3,200/200ml bottles
- Distribution
- Worldwide Distribution --- USA including states of AZ, CA, FL, IA, ID, IL, IN, KY, LA, MD, NC, ND, NE, NY, OH, OK, PA, SD, TX, VA, WA, and WI, and country of Canada.
- Date initiated
- 2008-09-05
- Date posted
- 2008-12-03
- Date terminated
- 2012-04-25
- Location
- Westlake, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) (K002290) | Radiometer Medical A/S | 2000-09-13 |