The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1790-2014·Announced 2014-06-25

Roche MODULAR ANALYTICS EVO Serum Work Area Filter Recall

Roche Diagnostics is recalling 462 Serum Work Area filters for the MODULAR ANALYTICS EVO analyzer due to potential loose components that may cause discrepant results and system alarms.

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, and the source text describes functional defects (discrepant results, alarms) without reporting any hospitalizations, significant injuries, or deaths, aligning with the Moderate severity criteria for low-risk contamination or functional issues.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling 462 units of the Roche MODULAR ANALYTICS EVO Serum Work Area (SWA) filters. The affected product is a fully automated immunoassay analyzer component intended for the in-vitro quantitative and qualitative determination of analytes in body fluids. The recall covers filters with specific material numbers and a wide range of lot codes, distributed nationwide in the United States.

The recall is being issued because, under certain conditions, loose ProCell/CleanCell aspiration tube filters may cause consecutive discrepant results, sipper alarms, foam on reservoirs, and system reagent alarms. These issues can affect the reliability of the automated analysis process.

Healthcare facilities and laboratories that have purchased or received these specific filters should stop using them and contact Roche Diagnostics for instructions on replacement or return. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative…
Manufacturer
Roche Diagnostics Operations, Inc.
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
462

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 (20)

  • 1305-31
  • 1305-21
  • 1305-22
  • 1308-35
  • 1308-36
  • 130833
  • 130834
  • 1308-44
  • 1310-20
  • 1418-12
  • 1307-33
  • 1421-11
  • 1417-20
  • 1423-16
  • 143115
  • 1428-07
  • 1430-16
  • 1430-17
  • 1423-15
  • 1429-15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Roche Diagnostics Operations, 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 3 products in this recall →

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