S1730 Calibration Solution 2, 200 mL, packed in single unit plastic bottles, REF 944-025, used with ABL700 Series Blood Gas Analyzers.
This recall has been terminated (originally issued August 29, 2006).
- Company
- Radiometer America Inc
- Recall Initiated
- October 31, 2005
- Posted
- August 29, 2006
- Terminated
- April 17, 2012
- Recall Number
- Z-1460-06
- Quantity
- 638/200 mL plastic bottles.
- Firm Location
- Westlake, OH
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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
Lot / Code Info
Part #944-025, Lot QR-02, Expiration Date: September 2007.
Root Cause
Other
Action Taken
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.