The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2196-2013·Announced 2013-09-25

Assuramed Recalls DiaScreen Liquid Urine Controls Due to Storage Temperature Issues

Assuramed is recalling DiaScreen Liquid Urine Controls because they may have been stored at temperatures outside required conditions.

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 source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential loss of product efficacy due to storage conditions, which fits the criteria for a moderate severity recall involving low-risk contamination or precautionary measures without reported harm.

Plain-English summary

Assuramed is recalling 10 units of DiaScreen Liquid Urine Controls, Product Number D76004. These are positive and negative assayed liquid quality controls intended for use with dipsticks in routine urinalysis in clinical laboratories. The products were manufactured for ARKRAY USA, Inc.

The recall was initiated because the products may have been stored at temperatures outside their required storage conditions. This deviation from storage requirements could affect the reliability of the controls.

The affected products were distributed nationwide, including in AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH, OK, OR, SC, TX, UT, and WA. The recall includes all lots of Product Number D76004. Users should stop using these controls and contact the recalling firm for instructions.

The recalled product

Product
DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004 (4x12 mL bottles) consists of: 2x12mL Positive controls [and] 2x12mL Negative controls; Manufactured for ARKRAY USA, Inc.…
Manufacturer
Assuramed
Category
Medical Device — Laboratory Reagents
Hazard
Affected units
10

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 (3)

  • Product Number: D76004
  • Lots: All Lots
  • Independence Medical Catalog Number: CJD76004

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Assuramed 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 3 products in this recall →

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