Recall Z-1460-06 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radiometer America Inc
S1730 Calibration Solution 2, 200 mL, packed in single unit plastic bottles, REF 944-025, used with ABL700 Series Blood Gas Analyzers.
| Date | Aug 29, 2006 (initiated Oct 31, 2005) |
| Status | Terminated |
| Reason | Calibration solution for ABL700 Blood Gas Analyzers is labeled with an incorrect bar code. The bar code identified on the Cal Solution 2 product is actually the bar code for the rinse solution. |
| Root cause | Other |
| Action | Representatives of the recalling firm were informed of this problem and were asked to visit the firm''s customers and retrieve any of the suspect product found in inventory at each customer location for customer credit. The representatives were instructed to complete this action via a ''Management Cover e-mail issued on 10/31/2005. According to the Management Cover Memo, these actions were scheduled for completion by firm representatives on or before 12/15/2005. |
| Quantity | 638/200 mL plastic bottles. |
| Distribution | The recalled product was distributed to customers in following states nationwide: AL, AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV and WY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.