Abbott Laboratories Recalls 359 Million Diabetes Testing Strips due to Safety Hazards

Abbott Laboratories, a major US drug maker, has announced a massive recall of up to 359 million diabetes testing strips due to concerns over inaccurate low readings. The recall was initiated after an internal review at Abbott uncovered a manufacturing defect that caused certain lots of the strips to take too long to absorb blood from a patient's finger, potentially leading to inaccurate low readings of blood sugar levels. The FDA has warned that these inaccuracies may cause patients to either unnecessarily raise their blood sugar levels or fail to detect dangerously high levels.

Key Takeaways:

• The recall affects up to 359 million diabetes testing strips made between January and May 2010.
• The strips, sold under six brand names, were used for testing blood sugar levels in both consumers and healthcare facilities.
• The FDA has issued a warning that inaccurately low measurements by the strips may lead to patient harm.
• The affected products were only distributed in the US and Puerto Rico.
• Abbott and FDA are reviewing the cause of the manufacturing defect to avoid it in the future.
• The recall does not affect all Abbott diabetes testing strips.
• Consumers and healthcare facilities using the recalled strips have been advised not to use them and will be supplied with new strips at no cost.

Statistics:

• 359 million: The number of diabetes testing strips recalled by Abbott Laboratories.
• January to May 2010: The time period during which the recalled strips were made.
• 6: The number of brand names under which the recalled strips were marketed (Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ, and ReliOn Ultima).
• US and Puerto Rico: The regions in which the affected products were distributed.

Sources:

• "U.S. drug maker Abbott Laboratories recalls up to 359 million diabetes testing strips due to safety hazards." Xinhua News Agency, via COMTEX, 22 Dec 2010.
• "FDA and Abbott reviewing cause of diabetes testing strip defect." Food and Drug Administration, 22 Dec 2010.