BD PCR Cartridges used with MAX System. Model Number: 437519
Reported: January 29, 2025 Initiated: December 19, 2024 #Z-1004-2025
Product Description
BD PCR Cartridges used with MAX System. Model Number: 437519
Reason for Recall
Potential for signal drift in specific lots of BD PCR Cartridges.
Details
- Recalling Firm
- Becton Dickinson & Co.
- Units Affected
- 516,435 units
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, South Korea, Taiwan, Australia, Singapore, Mexico, Hong Kong, India, Japan, Columbia, Brazil, Philippines, Argentina, New , Zealand, Uruguay, Chile, Trinidad and Tobago, Belgium, Vietnam, Macao.
- Location
- Sparks, MD
Frequently Asked Questions
What product was recalled? ▼
BD PCR Cartridges used with MAX System. Model Number: 437519. Recalled by Becton Dickinson & Co.. Units affected: 516,435 units.
Why was this product recalled? ▼
Potential for signal drift in specific lots of BD PCR Cartridges.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 29, 2025. Severity: Moderate. Recall number: Z-1004-2025.
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