Abbott Multichem S Plus Quality Control Serum Recalled for Missing Dry Ice
Abbott Laboratories is recalling Technopath Multichem S Plus Level 1 quality control serum because units were delivered without required dry ice.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a packaging/shipping defect (missing dry ice) rather than a direct hazard to human health.
Plain-English summary
Abbott Laboratories is recalling Technopath Multichem S Plus Level 1, an assayed quality control serum used to monitor the precision of laboratory testing procedures. The recall was initiated because the devices were delivered without the required dry ice.
The affected product is identified by Lot 18004181 and Code LN 5P78-10. The distribution pattern indicates that the product was distributed to Latvia. The quantity involved is 1 unit.
Consumers and laboratories should stop using the affected product and contact Abbott Laboratories for further instructions or a replacement.
The recalled product
- Product
- Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
- Manufacturer
- Abbott Laboratories
- Affected units
- 1
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 (2)
- LN 5P78-10
- Lot 18004181
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 9 recalled by Abbott Laboratories under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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