The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1059-2013·Announced 2013-04-10

Polymedco OC-Light iFOBT Test Strips Recalled for Potential False Negatives

Polymedco is recalling OC-Light iFOBT test strips because they may not be stable through their labeled shelf-life, potentially causing false negative results.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of false negative results for a medical test, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Polymedco, Inc. is recalling 355,350 test strips packaged in the OC-Light Manual iFOBT Kit (Catalog No. FOB50). These test strips are used for the rapid, qualitative detection of human hemoglobin in feces. The affected lots were distributed nationwide in the United States, including Puerto Rico, as well as in Canada and Guam.

The recall was initiated because the test strips may not be stable through their labeled shelf-life. This instability creates a possibility of obtaining false negative results when using the affected lots. Specific lot numbers and expiration dates for the affected kits and test strips are listed in the agency's structured product information.

Consumers who have purchased these specific lots should stop using the test strips and contact Polymedco, Inc. for further instructions or a replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.
Manufacturer
Polymedco, Inc
Category
Medical Device — Diagnostic Test
Hazard
Affected units
355,350

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 (12)

  • Kit Lot # P205877 - Kit Expiration Date 2/28/2013 - Test Strip Lot # 18004M
  • Kit Lot # P210125 - Kit Expiration Date 3/31/2013 - Test Strip Lot # 19006M
  • Kit Lot # P210204 - Kit Expiration Date 3/31/2013 - Test Strip Lot # 19006M
  • Kit Lot # P212420 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M
  • Kit Lot # P212421 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M
  • Kit Lot # P210194 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X010M
  • Kit Lot # P217043 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y012M
  • Kit Lot # P234499 - Kit Expiration Date 11/30/2013 - Test Strip Lot # 25011M
  • Kit Lot # P234664 - Kit Expiration Date 11/30/2013 - Test Strip Lot # 26012M
  • Kit Lot # P238025 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26012M
  • Kit Lot # P238028 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26013M
  • Kit Lot # P243938 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26012M.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Polymedco, Inc 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.

See all 2 products in this recall →

Related recalls

Same manufacturer · Polymedco, Inc

See all →

Same hazard · false negative result

See all →

Similar recalls