| Class 3 Device Recall Qualicheck Level 2 control solution | |
Date Initiated by Firm | May 24, 2005 |
Date Posted | August 02, 2006 |
Recall Status1 |
Terminated 3 on February 24, 2012 |
Recall Number | Z-1316-06 |
Recall Event ID |
35773 |
Product Classification |
package insert - Product Code GKF
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Product | Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of Hematocrits and Metabolites, used with the ABL 77/70/555 Blood Gas & Electrolyte Analyzers. The QC reagents are packaged in a box of 30 glass vials of (1.5 ml) per box. The package insert is packed one per box. |
Code Information |
Model #.S7180, Part Number: 944040, Lot #15. |
Recalling Firm/ Manufacturer |
Radiometer America Inc 810 Sharon Dr Westlake OH 44145-1598
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For Additional Information Contact | Vince Sigmund 800-736-0600 |
Manufacturer Reason for Recall | The package insert, which accompanied the QC reagents used with ABL blood gas analyzers, referenced incorrect control ranges for Hct (hematocrit) testing. The range stated on the package insert was too low to generate accurate Hct test results (The control ranges were acceptable for the glucose and lactate testing). |
FDA Determined Cause 2 | Other |
Action | The firm apprised their customers of this situation with a letter dated 5/24/2005. The letter requests that the customer remove the old (incorrect) package insert and replace it with a new (correct) insert which accompanied the customer letter. Should the customer have any questions, or need additional package inserts, the letter provides a toll-free contact telephone number. |
Quantity in Commerce | 55 boxes x 1 package insert per box |
Distribution | Nationwide, including: PA, MI, NY, OH, NJ, TX, AL, MO, AR, TN, WA, KY, and NC, and London, ON, Canada |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = GKF 510(K)s with Product Code = GKF
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