Tosoh AIA Analyzer Pipette Tips Recalled Due to Size Inconsistency
Tosoh Smd Inc is recalling AIA Analyzer Pipette Tips because visual inspection found some tips were not uniform in size or length, causing error messages on analyzers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to equipment error messages caused by physical size inconsistencies, with no reported injuries or health consequences.
Plain-English summary
Tosoh Smd Inc is recalling AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900, and AIA-600II Analyzers. The recall involves 11,309 bags of disposable pipette tips packaged in bulk quantities. These tips are used for lab analysis of various immunoassays.
The recall was initiated after visual inspection indicated that some of the tips were not uniform in size or length. This inconsistency was causing error messages on the analyzers. The affected lot numbers are 060811, 070111, B11, B11-12/23/2011, B12-02/07/2012, B12-04/30/2012, B12-06/01/2012, B12-08/06/2012, B12-09/05/2012, B12-10/26/2012, and B12-11/27/2012.
The product was distributed worldwide, including in the United States (specifically AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY) and internationally to Canada, Japan, Mexico, Chile, and Uruguay. Users should check their inventory for the affected lot numbers and contact Tosoh Smd Inc for further instructions.
The recalled product
- Product
- AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyzers for lab analysis of various immunoassays.
- Manufacturer
- Tosoh Smd Inc
- Hazard
- Affected units
- 11,309
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- The following lots numbers are affected by this recall: 060811
- 070111
- B11
- B11-12/23/2011
- B12-02/07/2012
- B12-04/30/2012
- B12-06/01/2012
- B12-08/06/2012
- B12-09/05/2012
- B12-10/26/2012
- and B12-11/27/2012.
Distribution
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