Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas¿ CT/NG 4800 System, for in vitro diagnostics.
Reported: April 10, 2013 Initiated: March 1, 2013 #Z-1028-2013
Product Description
Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas¿ CT/NG 4800 System, for in vitro diagnostics.
Reason for Recall
Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir. As a consequence, pipetting errors can occur due to uneven distribution of reagent. These pipetting errors may lead to delayed results and wasted reagent.
Details
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Units Affected
- 189 units
- Distribution
- Nationwide Distribution including Puerto Rico and the states of MO, NE, CO, MT, NJ, FL, WA, TX, GA, NY, KS, NH, VA, HI, PA, MI, IA, CA, NC, AZ, UT, LA, IL, TN, ME, MN, KY, CT, OR, NV, AL and NM.
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas¿ CT/NG 4800 System, for in vitro diagnostics.. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 189 units.
Why was this product recalled? ▼
Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir. As a consequence, pipetting errors can occur due to uneven distribution of reagent. These pipetting errors may lead to delayed results and wasted reagent.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 10, 2013. Severity: Moderate. Recall number: Z-1028-2013.
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